A Study to Evaluate Subjects With Turner Syndrome Treated With Growth Hormone

This study is ongoing, but not recruiting participants.

First Received on November 24, 2004. Last Updated on November 11, 2010 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00097552

Purpose

This study is a multicenter, open-label, observational, postmarketing surveillance study of Genentech growth hormone (GH) products in the treatment of girls with Turner syndrome in the United States and Canada.

Condition	Phase
Turner Syndrome	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Characterization of Subjects With Turner Syndrome Treated With Growth Hormone in the National Cooperative Growth Study (NCGS)

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome persistent Müllerian duct syndrome tetrasomy 18p Turner syndrome

MedlinePlus related topics: Turner Syndrome

U.S. FDA Resources

Further study details as provided by Genentech:

Enrollment:	1696
Study Start Date:	May 1997
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic

Criteria

Inclusion Criteria:

Are girls with Turner syndrome who are being or will be treated with Nutropin, Nutropin AQ, or Protropin
Are willing to keep follow-up appointments throughout study participation
Are girls with Turner syndrome who have submitted Form 4 upon discontinuation and may also submit Form 9

Exclusion Criteria:

Have Noonan syndrome
Subjects treated within the last 6 months with a non-Genentech GH preparation
Have closed epiphyses prior to NCGS enrollment
Have active neoplasia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097552

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Barbara Lippe, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00097552 History of Changes
Other Study ID Numbers:	85-036, Substudy 9
Study First Received:	November 24, 2004
Last Updated:	November 11, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders

Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012